PhysIQ Heart Rhythm And Respiration Module

Electrocardiograph

PhysIQ, Inc

The following data is part of a premarket notification filed by Physiq, Inc with the FDA for Physiq Heart Rhythm And Respiration Module.

Pre-market Notification Details

Device IDK193415
510k NumberK193415
Device Name:PhysIQ Heart Rhythm And Respiration Module
ClassificationElectrocardiograph
Applicant physIQ, Inc 300 E. 5th Avenue, Suite 105 Naperville,  IL  60563
ContactGeorge Allen Hides
CorrespondentGeorge Allen Hides
physIQ, Inc 300 E. 5th Avenue, Suite 105 Naperville,  IL  60563
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-09
Decision Date2020-06-11

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